The U.S. Food and Drug Administration granted accelerated approval to durvalumab (Imfinzi) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Read the full press release.

The U.S. Food and Drug Administration granted accelerated approval to brigatinib (Alunbrig) for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. Read the full press release.

The U.S. Food and Drug Administration expanded the indications of regorafenib (Stivarga) to include the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Read full press release.

The U.S. Food and Drug Administration approved atezolizumab (Tecentriq) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy. Read full press release.

The U.S. Food and Drug Administration approved pembrolizumab (Keytruda) for adult and pediatric patients with classical hodgkin lymphoma (cHL) refractory to treatment, or who have relapsed after three or more prior lines of therapy. Read the full press release.

The U.S. Food and Drug Administration granted accelerated approved to nivolumab (Opdivo) for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months or neoadjuvant or adjuvant treatment with a platinum containing chemotherapy. Read full press release.

06 Dec 2016 7:43 PM |
Anonymous

South San Francisco, CA -- December 6, 2016 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Avastin (bevacizumab), either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin alone, for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. Women are said to have a ‘platinum-sensitive’ form of the disease if a relapse occurs six months or longer following the last treatment with a platinum-based chemotherapy. Read full press release.